On May 5, Humanwell Pharmaceutical announced that its holding subsidiary Humanwell Pharmaceutical US, Inc.
(referred to as "Yichang Humanwell Pharmaceutical US Company") received the tentative approval number for tapentadol from the US FDA.
Tapentadol tablets are used to treat acute pain
Yichang Renfu Pharmaceutical USA submitted an ANDA application for tapentadol in 2020, with a cumulative R&D investment of approximately RMB 15 million
According to IQVIA statistics, the total sales of the drug (original drug) in the U.
market in 2021 will be approximately US$190 million.
The original drug belongs to Collegium, and manufacturers that have received tentative approval include Actavis, Alkem, Roxane, and Rhodes
There is currently no tapentadol in the domestic market.
Anhui Xinxing Drug Development Co.
, Jiangsu Enhua Pharmaceutical Co.
, Jiangsu Huatai Chenguang Pharmaceutical Co.
and the company's holding subsidiary Yichang Renfu Pharmaceutical Co.
Conduct clinical studies of tapentadol tablets
Currently, Collegium holds two patents for tapentadol, with expiration dates on August 5, 2022 and June 27, 2025, respectively
After the above patents expire and are officially approved, Yichang Renfu Pharmaceutical US Company can market the tapentadulo tablets that have obtained the ANDA approval number this time